Aflibercept for Neovascular age-related macular degeneration

Inclusion criteria

• {"criterion_text":"- Patients must be ≥50 years old on day 1.\n- All patients must be nAMD (neovascular age-related macular degeneration) treatment-naïve on the study eye.\n- All AMDs must be type 1 or 2.\n- Choroidal neovascularization lesion size have to be of nine or fewer disc areas.\n- For each participant, one eye will be chosen as the study eye. Should eligibility apply to both eyes, the one with the lower BCVA during the screening will be selected.\n- The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography.\n- The BCVA should be between 78 - 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at day 1."}

Exclusion criteria

• {"criterion_text":"- Participation in another clinical trial during the last 4 weeks.\n- Any cataract surgery within 3 months before day 1 or already scheduled during the study period on the study eye.\n- Any other intraocular surgery on the study eye (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant).\n- Polypoidal choroidal vasculopathy (PCV) or type 3 AMD confirmed by fluorescein and/or indocyanine green angiography on the study eye.\n- Simultaneous participation in another clinical trial.\n- Subjects who receive any intraocular surgery during the study period on the study eye.\n- Pregnancy or breast-feeding.\n- Current chemotherapy.\n- Known intolerance/hypersensitivity to aflibercept 8 mg.\n- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid (retinal detachment, diabetic maculopathy, epiretinal membrane with traction, central serous chorioretinopathy) on the study eye.\n- Retinal pigment epithelium (RPE) tear involving the macula on the study eye on day 1.\n- >6 diopters of myopia on the study eye (For patients who have undergone previous refractive or cataract surgery, the preoperative refractive error should not have exceeded −6 diopters of myopia)."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients without disease activity at week 8.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with a 4, 6, 8, 10, 12, 14 or 16 week treatment interval between the 2nd aflibercept 8 mg loading dose and the 3rd aflibercept 8 mg injection\n- Change in best corrected visual acuity from baseline to week 4 and 8.\n- Change in central subfield thickness and macular fluid volume from baseline to week 4 and 8.\n- Characteristics/measurements in optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), angiography and best corrected visual acuity (BCVA) assessment, which can predict active/non-active disease.","definition_or_measurement_approach":""}

Austria

Earliest CTIS Part Ii Submission Date

19-01-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria